Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis

Description

Explore the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach outcomes in functional dyspepsia and gastroparesis patients.

Conditions

Dyspepsia, Gastroparesis

Study Overview

Study Details

Study overview

Explore the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach outcomes in functional dyspepsia and gastroparesis patients.

Modulation of Gastric Sensitivity and Accommodation by Vagal Nerve Stimulation

Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis

Condition
Dyspepsia
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Volunteers, female and male, between 18 and 65 years of age.
  • 2. For healthy volunteers, ability to undergo MRI for up to 2 hours.
  • 3. For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes.
  • 4. For Gastroparesis patients, diagnosis will include the following criteria:
  • * symptoms of gastroparesis of at least 12 weeks duration (does not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness
  • * an idiopathic etiology
  • * abnormal gastric emptying scintigraphy (GES) results using a 4 hour low fat Egg Beaters® protocol within the last 6 months with either a gastric emptying rate \> 60% retention at 2 hours and/or \>10% retention at 4 hours.
  • 1. History gastric/esophageal surgery
  • 2. Any alternative treatment (e.g. acupuncture, hypnosis etc.) two weeks prior to the study or during the study period.
  • 3. Illicit drugs or opioid use.
  • 4. History of arrhythmias.
  • 5. Implanted pacemaker.
  • 6. Epilepsy or a prior history of seizures.
  • 7. For Gastroparesis patients, inability to comply with or complete GES test (including allergy to eggs).
  • 8. Pregnancy or nursing or plans to become pregnant.
  • 9. Inability to provide informed consent.
  • 10. BMI more than 32 and/or weight \> 235 lbs. (limits of the MRI table).
  • 11. Contraindications for MRI: High magnetic fields may pose a serious health hazard to subjects with implanted ferromagnetic objects. Every subject in this study will be carefully screened before entering the high magnetic field shielded room to collect a precise outline of the subject's medical history. Subjects with the following characteristics/disease may not be eligible to participate in the study and will require additional screening:
  • * History of Head Trauma
  • * Any metallic implants (e.g. braces or permanent retainers)
  • * Tattoos with metallic ink above the nipple line
  • * Surgical Aneurysm Clips
  • * Cardiac Pacemaker
  • * Prosthetic Heart Valve
  • * Neurostimulator
  • * Implanted pumps
  • * Cochlear Implants
  • * Metal rods, Plates, Screws
  • * Recent Previous Surgery
  • * IUD
  • * Hearing Aid
  • * Dentures (which might create NMR artifacts)
  • * Metal Injury to eyes
  • * Pregnancy or plans to become pregnant
  • * Breast Feeding
  • * Meniere's Disease
  • * Transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop, or Ortho Evra (birth control)
  • * Claustrophobia

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Massachusetts General Hospital,

Roberta Sclocco, PhD, PRINCIPAL_INVESTIGATOR, Spaulding Rehabilitation Hospital

Study Record Dates

2025-03-30